TangenX - Sius TM   Single Use Tangential Flow Filtration Cassettes Mark Perreault, TangenX Technology
TangenX TFF Membranes and Cassettes
TangenX Technology Corp.– Shrewsbury, MA <ul><li>TangenX founded in January 2004  -  Shrewsbury, MA </li></ul><ul><li>Nova...
 
 
 
 
TangenX Overview  Ultrafiltration Membranes
TangenX Membranes - mPES
TangenX Membranes - mPES
TangenX Membranes - mPES
<ul><li>“ Single Cast”, uniquely controllable process </li></ul><ul><ul><li>Reduced number of manufacturing steps </li></u...
TangenX mPES Membranes Two (2) Membrane Chemistries <ul><li>Modified Polyethersulfone (PES) membranes: </li></ul><ul><li>P...
<ul><li>TangenX offers two membrane chemistries; ProStream and HyStream </li></ul><ul><li>Available in multiple cutoff’s: ...
TangenX Membranes - mPES
TangenX Membranes - mPES
<ul><li>TangenX membranes demonstrate exceptional selectivity when challenged with “model” proteins in solution </li></ul>...
TangenX Membranes - mPES <ul><li>Typical 3 to 6 rule for MWCO selection </li></ul>
<ul><li>Better selectivity allows users to use a higher MWCO membrane for improved flux.  </li></ul><ul><li>TangenX membra...
100KD ProStream mPES  MAb Optimization – 10mg/ml
TangenX Membranes - mPES <ul><li>Typical 3 to 6 rule for MWCO selection </li></ul>
<ul><li>When fractionating, better selectivity allows users to separate molecules closer in molecular weight.  </li></ul><...
<ul><li>TangenX membranes offer greater flux & selectivity than traditional mPES </li></ul>TangenX Membranes - mPES
TangenX - Sius TM   Single Use Tangential Flow Filtration Cassettes
ISPE Carolina South-Atlantic Chapter Sius TM  Single-Use TFF Cassettes <ul><li>Single-use technology has made bioprocesses...
ISPE Carolina South-Atlantic Chapter Sius TM  Single-Use TFF Cassettes
Sius TM  Single-Use TFF Cassettes
Sius TM  Single-Use TFF Cassettes
<ul><ul><li>The first truly disposable TFF cassette design </li></ul></ul><ul><ul><li>The Sius TM  cassette incorporates a...
<ul><li>Full range of formats and MWCO (molecular weight cut offs) </li></ul><ul><li>Pre-sanitized with 0.2M Sodium Hydrox...
<ul><ul><li>Sius TM -LS – from laboratory to small pilot scale </li></ul></ul><ul><ul><li>Available in 0.1m 2 , 0.2m 2 , a...
“ L” Screen 1.0mm Open Channel Flow Spacers   Low Viscosity High Viscosity & Particulates 0.5mm Open Channel Membrane Flow...
<ul><li>Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use f...
<ul><li>Sius TM  Single Use TFF Cassettes utilize an innovative 2 stage assembly process </li></ul><ul><li>Membranes and p...
<ul><li>Materials of Construction </li></ul><ul><ul><li>Membrane PES </li></ul></ul><ul><ul><li>Membrane Support Polypropy...
Product Support – Validation Guide
Product Support – C of C
Product Support – Product Use
Product Support – Product Use
<ul><li>Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use f...
Single Use - Summary <ul><li>Single-Use TFF eliminates the need to flush with costly purified water or measure water perme...
TangenX - NovaSet TM   Tangential Flow Filtration Cassettes
NovaSet TM -LS Reusable TFF Cassette
NovaSet TM  Reusable TFF Cassette
NovaSet TM  Reusable TFF Cassette
NovaSet TM  Reusable TFF Cassette
NovaSet TM - Feed Channel Options Low Viscosity High Viscosity & Particulates Higher Cross Flow Velocity Lower Cross Flow ...
NovaSet TM  Reusable TFF Cassette
NovaSet TM  Reusable TFF Cassette
NovaSet TM  Reusable TFF Cassette NovaSet™ Cassette 0.5, 1.5 or 2.5m 2   <ul><li>Specifications </li></ul><ul><ul><li>Maxi...
<ul><li>Sius and NovaSet cassettes provide an interchangeable TFF platform </li></ul><ul><li>Same membrane used in both pr...
<ul><li>Pressure drop vs. crossflow rate confirms scalability within the same product family </li></ul><ul><li>Also confir...
NovaSet TM  vs. Sius TM   TFF Cassette Performance <ul><ul><li>5 mg/ml BSA </li></ul></ul><ul><ul><li>TMP 25psi </li></ul>...
  TangenX -  TFF Cassette Holders for NovaSet TM   and  Sius TM
BioPharm TFF – Laboratory
BioPharm TFF – Pilot
BioPharm TFF – Process <ul><li>NovaSet-75 Hydraulic TFF Cassette Holder </li></ul><ul><li>NovaSet-300 Hydraulic TFF Casset...
  TangenX - Sius TM   Filter Plate Insert (FPI)
<ul><ul><li>The FPI follows the disposable TFF cassette design </li></ul></ul><ul><ul><li>FPI direct retrofits for all exi...
Filter Plate Insert (FPI)
System Design <ul><li>Insert plates may be used with existing filter holders by replacing cassettes </li></ul><ul><li>All ...
<ul><li>Type 304L/316 Stainless Steel </li></ul><ul><ul><li>Clamp Base, Cover </li></ul></ul><ul><ul><li>Washers / Spacers...
Insert Plate Features <ul><li>Each plate has (1) set of Feed/Retentate Ports and (1) set of Filtrate Ports </li></ul><ul><...
<ul><li>Similar design and function to process plates </li></ul><ul><li>To be used in NovaSet-LS hardware </li></ul>FPI - ...
Options <ul><li>Mini T/C or 1&quot; T/C Fitting replaces Barb (not shown) </li></ul><ul><li>Analog Gauge Option </li></ul>...
<ul><ul><li>The filter plate inserts (FPI) are available for Beta testing – June 09 </li></ul></ul><ul><ul><li>The functio...
TangenX Overview  Thank You For Your Attention
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Tx Single Use Seminar Jun09

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Tx Single Use Seminar Jun09

  1. 1. TangenX - Sius TM Single Use Tangential Flow Filtration Cassettes Mark Perreault, TangenX Technology
  2. 2. TangenX TFF Membranes and Cassettes
  3. 3. TangenX Technology Corp.– Shrewsbury, MA <ul><li>TangenX founded in January 2004 - Shrewsbury, MA </li></ul><ul><li>Novasep acquires a controlling interest in TangenX effective September 1, 2006 </li></ul><ul><li>TangenX and Novasep introduce validated TFF reusable products at IBC in Boston, October 2007 </li></ul><ul><li>TangenX and Novasep introduce industry’s first validated TFF reusable products at IBC in California, Dec. 2008 </li></ul><ul><li>+ 40 years Membrane and TFF Experience </li></ul>
  4. 8. TangenX Overview Ultrafiltration Membranes
  5. 9. TangenX Membranes - mPES
  6. 10. TangenX Membranes - mPES
  7. 11. TangenX Membranes - mPES
  8. 12. <ul><li>“ Single Cast”, uniquely controllable process </li></ul><ul><ul><li>Reduced number of manufacturing steps </li></ul></ul><ul><ul><ul><li>Lower cost and excellent consistency and reliability </li></ul></ul></ul><ul><ul><li>Tightly controlled microporous/UF transition interface. </li></ul></ul><ul><ul><ul><li>Balanced flux and selectivity </li></ul></ul></ul><ul><ul><ul><li>No breakthrough of the UF skin </li></ul></ul></ul><ul><ul><ul><li>Macroporous substructure for maximized flux </li></ul></ul></ul>SEM X-Section of the ProStream 100KD <ul><ul><ul><li>Integral “cast-modification” of the membrane surface chemistry </li></ul></ul></ul><ul><ul><ul><ul><li>Addition of a second (hydrophilic) polymer into the pre-casting membrane solution </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Consistent surface modification that deliver </li></ul></ul></ul></ul><ul><ul><ul><li>Lower protein binding </li></ul></ul></ul><ul><ul><ul><li>Excellent chemical resistance </li></ul></ul></ul>TangenX Membranes - mPES
  9. 13. TangenX mPES Membranes Two (2) Membrane Chemistries <ul><li>Modified Polyethersulfone (PES) membranes: </li></ul><ul><li>ProStream TM : 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm </li></ul><ul><ul><li>Neutrally Balanced Charge </li></ul></ul><ul><ul><li>Low Protein Binding </li></ul></ul><ul><li>HyStream TM : 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm </li></ul><ul><ul><ul><ul><li>Hydrophilic - Minimal fouling with hydrophobic molecules </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Low Protein Binding </li></ul></ul></ul></ul>ProStream TM 10 kD (1000X) HyStream TM 10 kD (1000X)
  10. 14. <ul><li>TangenX offers two membrane chemistries; ProStream and HyStream </li></ul><ul><li>Available in multiple cutoff’s: 1kD, 3kD, 5kD, 10kD, 30kD, 50kD, 100kD, 300kD, 0.1µm, 0.2µm </li></ul><ul><li>ProStream </li></ul><ul><li>mPES membrane cast on a polypropylene non-woven </li></ul><ul><li>The membrane is neutrally charged, rendering it low binding for enhanced flux and recovery </li></ul><ul><li>The membrane has excellent chemical resistance and very low extractables. </li></ul><ul><li>HyStream </li></ul><ul><li>mPES membrane also cast on a polypropylene non-woven </li></ul><ul><li>It’s modification renders it extremely hydrophilic in nature, resisting fouling from hydrophobic species such as fat, lipids, and various antifoam agents. </li></ul><ul><li>The membrane has good chemical resistance and offers an alternative to RC membranes in some cases. </li></ul>ProStream 10KD HyStream 10KD TangenX Membranes - mPES (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) (+) (-) ProStream (+/-) (+/-) (+/-) (+/-) (+/-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) (-) Un-Modified PES (+) (+) (+) (+) (+) (+)
  11. 15. TangenX Membranes - mPES
  12. 16. TangenX Membranes - mPES
  13. 17. <ul><li>TangenX membranes demonstrate exceptional selectivity when challenged with “model” proteins in solution </li></ul><ul><li>Membranes were challenged with model proteins and the protein rejection was quantified </li></ul><ul><li>The rejection of each protein for a given MWCO membrane was plotted against the protein’s molecular weight </li></ul><ul><li>The selectivity curves generated show discrete selectivity profiles with no overlap </li></ul>Membrane Selectivity Curves for: ProStream Membranes HyStream Membranes Contact Angle Measurement (water at 20 o C) HyStream SEM of the HyStream 0.1um surface at 20,000X Data generated in triplicate using 13cm2 stirred cells TangenX Membranes - mPES
  14. 18. TangenX Membranes - mPES <ul><li>Typical 3 to 6 rule for MWCO selection </li></ul>
  15. 19. <ul><li>Better selectivity allows users to use a higher MWCO membrane for improved flux. </li></ul><ul><li>TangenX membranes can completely retain molecules as little as 2X different in MW. </li></ul><ul><li>Example: </li></ul><ul><ul><li>TangenX 100KD ProStream modified PES </li></ul></ul><ul><ul><li>Purified MAb concentration, 10mg/ml - (~150KD) </li></ul></ul><ul><ul><li>Typical flux is 90 to 100 LMH </li></ul></ul><ul><ul><li>Greater than 99% retention </li></ul></ul>TangenX Membranes - mPES
  16. 20. 100KD ProStream mPES MAb Optimization – 10mg/ml
  17. 21. TangenX Membranes - mPES <ul><li>Typical 3 to 6 rule for MWCO selection </li></ul>
  18. 22. <ul><li>When fractionating, better selectivity allows users to separate molecules closer in molecular weight. </li></ul><ul><li>TangenX membranes can fractionate molecules as little as 2X different in MW. </li></ul><ul><li>Example: </li></ul><ul><ul><li>TangenX 100KD ProStream modified PES </li></ul></ul><ul><ul><li>Purified BSA concentration, 1.0mg/ml - (67KD) </li></ul></ul><ul><ul><li>Typically less than10% retention means BSA is not retained by the 100KD membrane </li></ul></ul>TangenX Membranes - mPES
  19. 23. <ul><li>TangenX membranes offer greater flux & selectivity than traditional mPES </li></ul>TangenX Membranes - mPES
  20. 24. TangenX - Sius TM Single Use Tangential Flow Filtration Cassettes
  21. 25. ISPE Carolina South-Atlantic Chapter Sius TM Single-Use TFF Cassettes <ul><li>Single-use technology has made bioprocesses: </li></ul><ul><ul><li>Cleaner </li></ul></ul><ul><ul><li>Safer </li></ul></ul><ul><ul><li>More Efficient </li></ul></ul><ul><li>Single-use technology has enabled a typical purification process to eliminate numerous costly clean in place (CIP) operations </li></ul>
  22. 26. ISPE Carolina South-Atlantic Chapter Sius TM Single-Use TFF Cassettes
  23. 27. Sius TM Single-Use TFF Cassettes
  24. 28. Sius TM Single-Use TFF Cassettes
  25. 29. <ul><ul><li>The first truly disposable TFF cassette design </li></ul></ul><ul><ul><li>The Sius TM cassette incorporates a unique patented* design with a more automated process for assembly. </li></ul></ul><ul><ul><li>Cassettes are direct retrofits for all existing TFF devices </li></ul></ul>*patent pending Sius TM Single-Use TFF Cassettes
  26. 30. <ul><li>Full range of formats and MWCO (molecular weight cut offs) </li></ul><ul><li>Pre-sanitized with 0.2M Sodium Hydroxide </li></ul><ul><li>Certified low TOC and endotoxin </li></ul><ul><li>Equilibrate & ready-to-use </li></ul><ul><li>Economic TFF Solution </li></ul>Benifits – Sius TM Cassettes
  27. 31. <ul><ul><li>Sius TM -LS – from laboratory to small pilot scale </li></ul></ul><ul><ul><li>Available in 0.1m 2 , 0.2m 2 , and 1.0m 2 </li></ul></ul><ul><ul><li>Stack cassettes up to 0.5m 2 </li></ul></ul><ul><ul><li>Sius TM – from pilot to process scale </li></ul></ul><ul><ul><li>Available in 0.5m 2 , 1.5m 2 , and 2.5m 2 </li></ul></ul><ul><ul><li>Stack cassettes up to 7.5m 2 </li></ul></ul>Linear Scalability – Sius TM Cassettes
  28. 32. “ L” Screen 1.0mm Open Channel Flow Spacers Low Viscosity High Viscosity & Particulates 0.5mm Open Channel Membrane Flow Spacers Lower Cross Flow Rate Higher Cross Flow Rate Higher Cross Flow Velocity Lower Cross Flow Velocity Channel Options – Sius TM Cassettes
  29. 33. <ul><li>Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use for demanding biopharmaceutical applications. </li></ul><ul><li>The Sius™-LS laboratory scale and Sius™ process scale TFF cassettes are purpose-built for single use processing with optimal performance that is equivalent to our NovaSet reusable product line. </li></ul><ul><li>Each c assette is manufactured in a fully validated and documented manufacturing process according to the principles of cGMP and meet specified release criteria. </li></ul><ul><li>Cassettes are manufactured using approved standard operating procedures and individually tested for both air integrity and hydrodynamic performance. </li></ul>Manufacturing – Sius TM Cassettes
  30. 34. <ul><li>Sius TM Single Use TFF Cassettes utilize an innovative 2 stage assembly process </li></ul><ul><li>Membranes and permeate channels are bonded together </li></ul>Manufacturing – Sius TM Cassettes <ul><li>Retentate channels consist of rigid plastic frames and turbulence promoting screens </li></ul><ul><li>The assembly is instantly bonded together using medical grade silicone pressure sensitive adhesive </li></ul><ul><li>Benefits </li></ul><ul><ul><ul><li>Process mfg. efficiency greatly improved </li></ul></ul></ul><ul><ul><ul><li>Reduced costs </li></ul></ul></ul><ul><ul><ul><li>Reduces lot rejection </li></ul></ul></ul>Patent Pending
  31. 35. <ul><li>Materials of Construction </li></ul><ul><ul><li>Membrane PES </li></ul></ul><ul><ul><li>Membrane Support Polypropylene </li></ul></ul><ul><ul><li>Screen Polypropylene </li></ul></ul><ul><ul><li>Channel Spacer HDPE </li></ul></ul><ul><ul><li>Filtrate Seals Urethane </li></ul></ul><ul><ul><li>Gasket EPDM </li></ul></ul><ul><li>Specifications </li></ul><ul><ul><li>Maximum Pressure </li></ul></ul><ul><ul><ul><li>7 bar (100 psi) forward; 0.33 bar (3 psi) reverse </li></ul></ul></ul><ul><ul><li>Air Integrity </li></ul></ul><ul><ul><ul><li>UF cassette ≤ 30 sccm @ 1 bar (15 psi) </li></ul></ul></ul><ul><ul><ul><li>MF cassette ≤ 30 sccm @ 0.2 bar (3 psi) </li></ul></ul></ul><ul><ul><li>Recirculation Flow </li></ul></ul><ul><ul><ul><li>'L' Screen 6-9 lpm/m2 @ 0.7 bar (10 psi) </li></ul></ul></ul><ul><ul><ul><li>'J' Channel 1-1.5 lpm /m2 @ 0.3 bar (1.5 psi) </li></ul></ul></ul><ul><li>Manufacturing </li></ul><ul><ul><li>Fully validated process, developed and documented in accordance with cGMP principles </li></ul></ul><ul><ul><li>Quality Control lot release testing includes 100% device integrity and hydrodynamic testing </li></ul></ul><ul><ul><li>Sanitized and packaged in 0.2M NaOH </li></ul></ul><ul><ul><li>Manufacturing process is fully validated, a validation guide is available to reference </li></ul></ul>Specifications – Sius TM Cassettes
  32. 36. Product Support – Validation Guide
  33. 37. Product Support – C of C
  34. 38. Product Support – Product Use
  35. 39. Product Support – Product Use
  36. 40. <ul><li>Sius™ cassettes have been designed and constructed using FDA approved materials that have been validated for use for demanding biopharmaceutical applications. </li></ul><ul><li>The Sius™-LS laboratory scale and Sius™ process scale TFF cassettes are purpose-built for single use processing with optimal performance that is equivalent to our NovaSet reusable product line. </li></ul><ul><li>Each c assette is manufactured in a fully validated and documented manufacturing process according to the principles of cGMP and meet specified release criteria. </li></ul><ul><li>Internally audited by Novasep QA </li></ul><ul><li>Cassettes are manufactured using approved standard operating procedures and individually tested for both air integrity and hydrodynamic performance. </li></ul>Product Support – Manufacturing
  37. 41. Single Use - Summary <ul><li>Single-Use TFF eliminates the need to flush with costly purified water or measure water permeability rates, saving time and resources. </li></ul><ul><li>Pre-Sanitized cassettes are installed, equilibrated with buffer, and used in processing. </li></ul><ul><li>Development work, scale up and processing can be conducted nearly 50% faster without the need for membrane cleaning and measurement or water flux recovery. </li></ul><ul><li>Cassette performance is more consistent from run to run as each process occurs using a new membrane. </li></ul><ul><li>Cross-contamination is minimized with single-use cassettes. </li></ul>
  38. 42. TangenX - NovaSet TM Tangential Flow Filtration Cassettes
  39. 43. NovaSet TM -LS Reusable TFF Cassette
  40. 44. NovaSet TM Reusable TFF Cassette
  41. 45. NovaSet TM Reusable TFF Cassette
  42. 46. NovaSet TM Reusable TFF Cassette
  43. 47. NovaSet TM - Feed Channel Options Low Viscosity High Viscosity & Particulates Higher Cross Flow Velocity Lower Cross Flow Velocity Lower Cross Flow Rate Higher Cross Flow Rate “ H” Screen Membrane Suspended Screen Flow Spacers “ L” Screen
  44. 48. NovaSet TM Reusable TFF Cassette
  45. 49. NovaSet TM Reusable TFF Cassette
  46. 50. NovaSet TM Reusable TFF Cassette NovaSet™ Cassette 0.5, 1.5 or 2.5m 2 <ul><li>Specifications </li></ul><ul><ul><li>Maximum Pressure </li></ul></ul><ul><ul><ul><li>7 bar (100 psi) forward; 0.33 bar (3 psi) reverse </li></ul></ul></ul><ul><ul><li>Recirculation Flow </li></ul></ul><ul><ul><ul><li>'H' Screen 6-9 lpm @ 1 bar (15 psi) </li></ul></ul></ul><ul><ul><ul><li>'L' Screen 6-9 lpm @ 0.7 bar (10 psi) </li></ul></ul></ul><ul><ul><ul><li>'S' Channel 1-1.5 lpm @ 0.3 bar (1.5 psi) </li></ul></ul></ul><ul><li>Manufacturing </li></ul><ul><ul><li>Fully validated process, developed and documented in accordance with cGMP principles </li></ul></ul><ul><ul><li>Quality Control lot release testing includes 100% device integrity and hydrodynamic testing </li></ul></ul><ul><ul><li>Individually packaged in a sealed foil lined bag and outer cardboard carton </li></ul></ul><ul><ul><li>Wet packed in 20% Glycerin and 0.1% Sodium Azide </li></ul></ul><ul><li>Materials of Construction </li></ul><ul><ul><li>Membrane: PES </li></ul></ul><ul><ul><li>Membrane Support: Polypropylene </li></ul></ul><ul><ul><li>Screen: Polypropylene </li></ul></ul><ul><ul><li>Encapsulant: Urethane </li></ul></ul><ul><ul><li>Gasket: Platinum Cured Silicone </li></ul></ul>
  47. 51. <ul><li>Sius and NovaSet cassettes provide an interchangeable TFF platform </li></ul><ul><li>Same membrane used in both products </li></ul><ul><li>Comparable cassette performance </li></ul><ul><li>TangenX cassettes allow scale up and scale down between both cassette formats </li></ul>NovaSet TM vs. Sius TM TFF Cassette Performance
  48. 52. <ul><li>Pressure drop vs. crossflow rate confirms scalability within the same product family </li></ul><ul><li>Also confirms interchangeability between family of cassettes </li></ul><ul><li>TangenX cassettes allow scale up and scale down between both cassette formats </li></ul>NovaSet TM vs. Sius TM TFF Cassette Performance
  49. 53. NovaSet TM vs. Sius TM TFF Cassette Performance <ul><ul><li>5 mg/ml BSA </li></ul></ul><ul><ul><li>TMP 25psi </li></ul></ul><ul><ul><li>CFF = 0.6L/min/ft 2 </li></ul></ul><ul><li>Flux and recovery comparable </li></ul><ul><li>TangenX cassettes allow scale up and scale down between both cassette formats </li></ul><ul><li>Application: 5X BSA concentration </li></ul>
  50. 54. TangenX - TFF Cassette Holders for NovaSet TM and Sius TM
  51. 55. BioPharm TFF – Laboratory
  52. 56. BioPharm TFF – Pilot
  53. 57. BioPharm TFF – Process <ul><li>NovaSet-75 Hydraulic TFF Cassette Holder </li></ul><ul><li>NovaSet-300 Hydraulic TFF Cassette Holder </li></ul>
  54. 58. TangenX - Sius TM Filter Plate Insert (FPI)
  55. 59. <ul><ul><li>The FPI follows the disposable TFF cassette design </li></ul></ul><ul><ul><li>FPI direct retrofits for all existing TFF devices </li></ul></ul><ul><ul><li>The filter plate insert system provides a disposable flow path for Sius cassettes </li></ul></ul>Disposable Flow Path for Sius TM Cassettes
  56. 60. Filter Plate Insert (FPI)
  57. 61. System Design <ul><li>Insert plates may be used with existing filter holders by replacing cassettes </li></ul><ul><li>All threaded connections in the fluid path are isolated by an o-ring – &quot;sanitary design“ </li></ul><ul><li>Low cost dedicated holder available </li></ul>System Design
  58. 62. <ul><li>Type 304L/316 Stainless Steel </li></ul><ul><ul><li>Clamp Base, Cover </li></ul></ul><ul><ul><li>Washers / Spacers </li></ul></ul><ul><ul><li>Screws </li></ul></ul><ul><li>Brass Nuts </li></ul><ul><ul><li>1-¼&quot; Socket Hex Nut </li></ul></ul><ul><li>Polyethyelene (Contact Surface) </li></ul><ul><ul><li>Filter Plate Insert </li></ul></ul><ul><ul><li>Barbed Fittings </li></ul></ul><ul><li>Polypropyelene (Contact Surface) </li></ul><ul><ul><li>Luer Lock Fittings </li></ul></ul><ul><li>EPDM (Contact Surface) </li></ul><ul><ul><li>O-Rings </li></ul></ul>Materials of Construction
  59. 63. Insert Plate Features <ul><li>Each plate has (1) set of Feed/Retentate Ports and (1) set of Filtrate Ports </li></ul><ul><li>Each plate has (2) male luer lock pressure tap connections (supplied with caps) </li></ul><ul><li>Plates are approximately 1&quot; thick with each port entrance clearly identified </li></ul><ul><li>Each plate is sanitized, dried and individually bagged </li></ul><ul><ul><li>Includes CofC/A for traceability </li></ul></ul><ul><li>Compatible with NovaSet reusable cassettes. </li></ul>Insert Plate Features
  60. 64. <ul><li>Similar design and function to process plates </li></ul><ul><li>To be used in NovaSet-LS hardware </li></ul>FPI - Laboratory Scale
  61. 65. Options <ul><li>Mini T/C or 1&quot; T/C Fitting replaces Barb (not shown) </li></ul><ul><li>Analog Gauge Option </li></ul>FPI - Options
  62. 66. <ul><ul><li>The filter plate inserts (FPI) are available for Beta testing – June 09 </li></ul></ul><ul><ul><li>The functionality of the FPI with competitor's holders is underway </li></ul></ul><ul><ul><li>Various hose barb and instrument connection ports are available, no standard has been established yet </li></ul></ul><ul><ul><li>Filter plate inserts will be provided with: </li></ul></ul><ul><ul><ul><li>MSDS (material safety data sheet) </li></ul></ul></ul><ul><ul><ul><li>COA (certificate of analysis) </li></ul></ul></ul><ul><ul><ul><li>COO (certificate of origin) BSE statement </li></ul></ul></ul><ul><ul><ul><li>shelf life </li></ul></ul></ul><ul><ul><ul><li>Extractables & leachables </li></ul></ul></ul>Current Status of FPI
  63. 67. TangenX Overview Thank You For Your Attention

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